Vol.69 No.3 May 2021

Phase III double-blind comparative study of intravenous lascufloxacin and levofloxacin in patients with community-acquired pneumonia

Makoto Miki¹⁾, Keiichi Mikasa²⁾, Junichi Kadota³⁾, Hiroshi Mukae⁴⁾, Jiro Fujita⁵⁾, Katsunori Yanagihara⁶⁾, Kazuhiro Tateda⁷⁾, Kyoichi Totsuka⁸⁾, Yasuko Umemoto⁹⁾, Sayoko Tanioka⁹⁾ and Shigeru Kohno¹⁰⁾

¹⁾Department of Respiratory Medicine, Japanese Red Cross Sendai Hospital, 2-43-3 Yagiyamahoncho, Taihaku-ku, Sendai, Miyagi, Japan
²⁾Nara Koseikai Hospital
Center for Infectious Diseases, Nara Medical University
³⁾Nagasaki Harbor Medical Center
(Past: Oita University Hospital)
⁴⁾Department of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences
⁵⁾Department of Infectious, Respiratory, and Digestive Medicine, Graduate School of Medicine, University of the Ryukyus
⁶⁾Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences
⁷⁾Department of Microbiology and Infectious Disease, Toho University School of Medicine
⁸⁾Department of Internal Medicine, Kita-tama Hospital
⁹⁾Clinical Development Center, Kyorin Pharmaceutical
¹⁰⁾Nagasaki University

Abstract

We conducted a randomized, double-blind, comparative phase III study to evaluate the efficacy and safety of intravenous lascufloxacin (LSFX) in comparison with intravenous levofloxacin (LVFX) in patients with community-acquired pneumonia (CAP). In the LSFX group, the subjects were administered LSFX 150 mg (300 mg on the initial day) by intravenous (iv) infusion once daily. In the LVFX group, the subjects were administered LVFX 500 mg by iv infusion once daily. Both investigational drugs were administered for a period of 7 to 14 days.
The cure rate at test-of-cure, as the primary endpoint, was 95.2% (119/125) in the LSFX group and 90.0% (108/120) in the LVFX group, demonstrating the non-inferiority of LSFX 150 mg to LVFX 500 mg. The results for the secondary endpoints were as follows: the early clinical efficacy rate on Day 3 was 93.2% (124/133) in the LSFX group and 94.0% (125/133) in the LVFX group; the clinical efficacy rate at end-of-treatment was 97.0% (128/132) in the LSFX group and 93.8% (120/128) in the LVFX group. The bacterial eradication rate by subject was 97.6% (41/42) in the LSFX group and 91.7% (44/48) in the LVFX group.
Adverse drug reactions were reported in 25.9% (37/143) in the LSFX group and 36.4% (52/143) in the LVFX group. No deaths or serious safety problems were noted with either drug.
Based on the results, LSFX 150 mg (300 mg on the initial day) administered iv once daily is expected to show a high efficacy from the early stage of administration, with no major safety problems, in patients with CAP, including atypical pneumonia.

Key word

community-acquired pneumonia, lascufloxacin, injection, clinical trial, levofloxacin

Received

October 5, 2020

Accepted

December 7, 2020

Jpn. J. Chemother. 69 (3): 255-269, 2021